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Safety Database Specialist

1-2 years
Not Disclosed
10 Oct. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Safety Associate

Job Summary
Due to our continued growth, Medpace is seeking qualified and focused individuals to join our Clinical Safety team. This vital role relies on your expertise and attention to detail. If you're ready to make a difference, we're looking for someone who can accomplish the following tasks:

Responsibilities

  • Implement routine system configuration, including product, study, and license management in Argus and Argus J.

  • Assist in creating reports using the Oracle Business Intelligence (OBIEE) reporting tool.

  • Resolve safety database-related issues.

  • Prepare and execute User Acceptance Testing (UAT) for safety system changes.

  • Assist in training new users on the Argus database as needed.

  • Generate outputs from the global safety system to support periodic safety reports (e.g., DSUR, PSUR, and PBRER).

  • Aid in the development of system support processes, SOPs, work instructions, and manuals.

  • Support inspection and audit activities.

Qualifications

  • Bachelor’s Degree in a scientific discipline, Business Informatics, or a related field, with 1-2 years of directly related experience.

Preferred Qualifications

  • Experience in a CRO, biotech, or pharmaceutical industry.

  • Familiarity with study configurations in safety systems.

  • Experience with safety databases, preferably Argus and Argus J.

  • Proficiency in SQL.

  • Experience with reporting and analytic platforms like OBIEE.

  • Strong client service orientation and consultative problem-solving skills.

  • Ability to combine technical problem-solving with business discernment.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. With headquarters in Cincinnati, Ohio, we leverage local regulatory and therapeutic expertise across major areas including oncology, cardiology, and more.

Why Medpace?

Joining Medpace means becoming part of a dedicated team that supports the development of groundbreaking drugs and devices, providing hope to those with debilitating diseases. We offer a competitive total compensation and benefits package along with internal growth opportunities.

Organic Growth

Medpace is expanding globally, with a new seven-story building at our Cincinnati headquarters and additional office locations in Dallas, TX, and Denver, CO.

Perks (vary by location and position)

  • On-site fitness centers and walking paths.

  • Company-sponsored social and wellness events.

  • Hybrid work-from-home options and flexible schedules.

  • On-site marketplace, restaurants, and banking services.

  • Free parking and discounts for local businesses.

Awards

  • Named a Top Cincinnati Workplace by the Cincinnati Enquirer.

  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021.

  • Continually recognized with CRO Leadership Awards for expertise, quality, and reliability.

What to Expect Next

A member of our recruitment team will review your qualifications. If you're a match, we’ll contact you for an interview.

EO/AA Employer M/F/Disability/Vets